Combined Collagen Crosslinking/Ultraviolet-A and Photorefractive Keratectomy or LASIK in Forme Fruste Keratoconus or Eyes With Potentially Elevated Risk of Ectasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cxlusa
- 入组人数
- 22
- 试验地点
- 7
- 主要终点
- Postoperative Best-Corrected Visual Acuity
研究概览
简要总结
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction.
详细描述
This study is being performed to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) in strengthening and optimizing the biomechanical and biochemical stability of the cornea in patients with fruste keratoconus (FFKC), corneas that are suspicious for FFKC and corneas thought to be at higher risk of developing ectasia that will be undergoing laser vision correction. CXL is thought to augment the tectonic strength of the cornea by using UVA light and the photo-mediator riboflavin. The purpose of this non-randomized study is to compare the visual results of patients who are suspicious for having an increased risk of ectasia with laser vision correction compared to a group of patients that does not have these risk factors. All excimer laser ophthalmic procedures currently being performed to correct myopia, hyperopia or astigmatism with FDA approved excimer lasers do so by removing corneal tissue and thereby potentially weakening the cornea biomechanically. This can result in ectasia even in patients without pre-existing risk factors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Up to 4 potential risk factors for ectasia
- •A. Abnormal Topography: Consistent with forme fruste keratoconus, forme fruste pellucid marginal degeneration, asymmetric astigmatism, or increased posterior float/posterior corneal surface shape.
- •B. Corneal thickness of 500 microns or less, as measured by ultrasound, Orbscan, or Pentacam
- •C. Age 18 to 25
- •D. Planned Residual stromal bed between 250 and 300 microns
- •Ability to provide written informed consent
- •Likely to complete all study visits
- •Best spectacle-corrected visual acuity (BSCVA) of 20/25 in each eye
- •Patients with and without previous laser vision correction are eligible for participation.
排除标准
- •Frank keratoconus, Pellucid, or Post-LASIK ectasia
- •Less than 20/30 BSCVA in either eye
- •Corneal scarring that markedly affects vision
- •Contraindications to any study medications or their components
- •Pregnancy or breast feeding
- •Active Herpes Corneal Disease
研究组 & 干预措施
low risk subjects for developing post-operative ectasia
Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
干预措施: Corneal Cross-Linking (Device)
low risk subjects for developing post-operative ectasia
Patients undergoing vision correction surgery who are not at a higher risk for developing post-op ectasia
干预措施: Riboflavin (Drug)
Subjects at Risk for Ectasia
Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
干预措施: Corneal Cross-Linking (Device)
Subjects at Risk for Ectasia
Patients undergoing vision correction surgery who are at a higher risk for developing post-operative ectasia
干预措施: Riboflavin (Drug)
结局指标
主要结局
Postoperative Best-Corrected Visual Acuity
时间窗: Month 9
次要结局
- Residual Refractive error at the 1, 3 and 6 month visits(Months 1, 3, and 6)